Exchangeable optics and therapeutics

ABSTRACT

An exchangeable optics system includes an intraocular base that can be fixed within an eye. The intraocular base includes one or more couplers and a supporting structure. The one or more couplers releasably couple to an exchangeable optic or therapeutic and can include magnetic material. The supporting structure can include haptics and a main structure that physically supports the exchangeable optic or the therapeutic that is coupled via the one or more couplers. In some cases, the intraocular base can include a fixed lens within or on the main structure. The exchangeable optic can include corresponding one or more couplers, which may be formed of magnetic material. The therapeutic can be in the form of a magnetic particle.

BACKGROUND

An intraocular lens (IOL) is a lens that is implanted in the eye. IOLscome in phakic, designed to be implanted without performing cataractsurgery, and pseudophakic, designed to be implanted in conjunction withcataract surgery, varieties. A phakic IOL has the ability to reside inthe sulcus space between the capsular bag and the iris or alternativelycan reside in the anterior chamber, between the iris and cornea. Themost commonly employed pseudophakic IOL is posterior chamber IOLincludes haptics that enable the lens to be held in place in thecapsular bag inside the eye. Implantation of an IOL is often carried outby an eye surgeon in a surgical center, but may be also be performed atan ophthalmologist's office in an in office surgical suite. In officeprocedures are particularly common with phakic IOLs, much in the sameway laser refractive surgeries are typically in office. The field ofpseudophakic IOLs is increasingly addressing the issue of presbyopia,which is the case where someone is not able to see both at distance andnear. Presbyopia is not an indication for insurance coverage of cataractsurgery currently.

As the field matures, it is likely IOLs will be increasingly utilized toaddress presbyopia, instead of glare and blurred vision even withglasses or some form of wearable refractive correction which is thecurrent indication. To achieve the quality of vision of laser refractivesurgery and to enable incremental changes to the lens as the technologyimproves, a means of fully customizable and upgradeable IOL design issorely needed. Refractive cataract surgery replaces the natural eye lenswith an advanced multi-focal or extended-depth-of-focus (EDOF) IOL.Refractive cataract surgery has not achieved the precision of cornealrefractive surgery, such as LASIK (laser-assisted in situkeratomileusis), which can be individualized to high precision.Moreover, there currently is a lack of wave-front guided precision incataract extraction and IOL implantation.

A wavefront-guided approach refers to an ablation profile that considerspreoperative higher-order aberrations, where the final goal is to avoidinducing aberrations and to eliminate some that exist. This is commonlyemployed with laser refractive surgery such as LASIK and PRK, as allvariables in the eye are known. The laser ablation profile is computedpreoperatively according to the results of aberrometry and istransferred to a laser system for use, for example, during surgery. Theonly modification made to the eye is to the shape of the cornea.Currently this is an elusive task in cataract surgery for two reasons.Principally, the effective lens position, where the IOL ends up in theeye, is hard to determine. Small changes in the anterior posteriorposition make large changes in the total power of the lens. In addition,zonular weakness induced by the surgery and change in cornealastigmatism made by the cataract main incision can respectively changethe lens position and the corneal curvature. Moreover, any customized,astigmatism and higher order aberration correction is precluded a priorion the IOL is precluded by potential shifting of the IOL within thecapsular bag in the X, Y, Z plane.

Outside of the inability to provide wavefront guided IOL optimization,current IOL systems do not enable ease of correction if a non-optimalIOL is placed, nor do they allow for ease of upgradeability. IOLexchange is a challenging procedure that even in the most skilledsurgeon's hands results in significant trauma to the ocular structures.So much so that IOL exchange is viewed as a last resort. However,repeated removal and replacement of a conventional IOL may not be aneasy procedure and can result in complications. For example, IOLexchange with the conventional IOLs requires dissection of the capsularbag and retrieval of an unfolded lens through the cornea or sclera.Either retrieval approach (through the cornea or through the sclera) ishighly traumatic to the eye and its delicate structures. Instead ofexchanging IOLs, most surgeons will perform LASIK or other laserrefractive procedure to the cornea. This also is not infinitelyrepeatable as corneal tissue is ablated at each procedure. Repeatedlaser correction can lead to a host of complications including cornealectasia and epithelial ingrowth. It also can induce ocular surfacedisease in even young patients and thus is less than ideal in many ofthe older individuals undergoing cataract surgery.

A need exists for a system that enables relatively unlimitedexchangeable optics as well as wavefront guided lens optimization.

BRIEF SUMMARY

Exchangeable optics and therapeutics are described that can enableprogressive application and exchanges of lenses and/or therapeutics inthe eye.

An exchangeable optics system includes an intraocular base that can befixed within an eye. The intraocular base includes one or more couplersand a supporting structure. The one or more couplers can includemagnetic material or other releasable fixation material or structures.For example, the releasable couplers can be in the form of a hook andloop coupler, a memory material fixation element such as what isutilized for tagging guns for affixing tags to clothing, a buttonfastener, a screw-type fastener, a hinge-based fastener similar to acuff link, a suction cup based mechanism, an adhesive, or any othermeans of reversible fixation.

Magnetic fixation is particularly attractive as the base element towhich the secondary optic couples can be in the capsular bag and themagnetic secondary optic can couple through magnetic force through theanterior capsular bag without physically directly contacting the IOL inthe bag. Magnetic attraction is also an ideal mechanism as it allows fora secondary optic to be disengaged from the primary optic with minimalforce. Accordingly for magnetic and other types of releasable couplers,it can be important to consider damage to delicate zonules that hold thecapsular bag. The supporting structure can include haptics and a mainstructure that physically supports an exchangeable optic or therapeuticthat is coupled via the one or more couplers. In some cases, theintraocular base can include a fixed lens within or on the mainstructure.

This Summary is provided to introduce a selection of concepts in asimplified form that are further described below in the DetailedDescription. This Summary is not intended to identify key features oressential features of the claimed subject matter, nor is it intended tobe used to limit the scope of the claimed subject matter.

BRIEF DESCRIPTION OF THE DRAWINGS

FIGS. 1A and 1B illustrate exchangeable optics systems suitable for animplantable intraocular lens and application of therapeutics.

FIGS. 2A-2E illustrate various locations in the eye where anexchangeable optics system can be set.

FIGS. 3A and 3B illustrate a perspective view and a top view,respectively, of an exchangeable optic with clips for coupling to anintraocular base.

FIG. 4 illustrates a perspective view of an exchangeable optic with ascrew mount for coupling to an intraocular base.

FIG. 5 illustrates a side view of part of an exchangeable optic systemwith a post and clip coupling.

FIGS. 6A-6D illustrate an exchangeable optics system with multiplestacked lenses.

FIGS. 7A and 7B illustrate another exchangeable optics system withmultiple stacked lenses; FIG. 7A shows another example of an intraocularbase; and FIG. 7B shows application of a second optic onto theintraocular base and first optic using a delivery system.

FIG. 8 illustrates an optic delivery system consisting of a hook thatcan be drawn coaxially within a delivery sleeve.

FIGS. 9A and 9B show fiducial designs that can enable preciseorientation of three-dimensional rotation of an optic or haptic.

FIG. 10 illustrates an example exchangeable optics system with magneticexchangeable intraocular lens.

FIGS. 11A-11D illustrate another example of an exchangeable opticssystem with magnetic exchangeable ocular lens.

FIGS. 12A-12D illustrate example haptic designs for exchangeable opticssystems.

FIGS. 13A and 13B illustrate a side view and top view, respectively, ofan exchangeable optic with rotatable lens.

FIGS. 14A-14C illustrate an example of an exchangeable optics systemwith therapeutic delivery.

FIGS. 15A-15C illustrate example magnetic liposomes or nanoparticlesthat can be used for delivery of therapeutics on an exchangeable opticssystem.

DETAILED DESCRIPTION

Exchangeable optics and therapeutics are described that can enableprogressive application and exchanges of lenses and/or therapeutics inthe eye.

FIGS. 1A and 1B illustrate exchangeable optics systems suitable for animplantable intraocular lens and application of therapeutics. As shownin FIGS. 1A and 1B, Exchangeable optics systems include an intraocularbase 100 that can be fixed within an eye. The intraocular base 100includes one or more couplers (e.g., coupler 110) and a supportingstructure 120. The one or more couplers can include magnetic material orother releasable fixation material or structures. In this example, asingle ring-shaped coupler 110 is shown.

Referring to FIG. 1A, an exchangeable optics system 130 can include anintraocular base 100 that supports an exchangeable optic (e.g., 140-A,140-B) and can be fixed within the eye. As mentioned above, theintraocular base 100 can include one or more couplers (e.g., coupler110) and a supporting structure 120. The one or more couplers, in thiscase, ring-shaped coupler 110, are used to releasably couple theintraocular base 100 to the exchangeable optic 140-A, 140-B. Thesupporting structure 120 can include haptics 150 for suturing orotherwise fixing the intraocular base 100 in the eye and a mainstructure 160 (which may be a circular substructure), which can be usedto physically support an exchangeable optic 140-A, 140-B directly orindirectly via the one or more couplers.

The haptics 150 can be any suitable structure enabling the intraocularbase 100 to be fixed within the eye. Various examples are shown in FIGS.6A, 7A, 10, 11A, and 12A-12D.

In the illustrated scenario, the main structure 160 is open in thecenter such that the exchangeable optic 140-A, 140-B rests on a proximalsurface at the perimeter of the intraocular base 100. In otherimplementations, the main structure 160 has a transparent surface overwhich the exchangeable optic 140-A, 140-B rests. The supportingstructure 120 can also optionally include a lens or IOL (not shown)within or on the main structure 160. In some cases, the supportingstructure 120 can include one or more protrusions that can be used toextend up through a hole in the capsular bag of the eye (see e.g.,extensions 222 of FIG. 2B and tension ring extensions 1125 of FIG. 11A).In some of such cases, a coupler can be disposed at an end of aprotrusion. This coupler may be the coupler for the base or anadditional coupler for the base.

The exchangeable optic 140-A, 140-B can include a lens 170 and one ormore corresponding couplers 180. For application of the exchangeableoptics system 130, the intraocular base 100 can be deployed in an eye.One of the exchangeable optics 140-A, 140-B can then be deployed,oriented/aligned, and coupled to the intraocular base 100 using thecouplers 110, 180 (illustrated as magnets/magnetic material). Alignmentcan involve radial alignment with respect to either the intraocularbase, the eye, or some structure within the eye. The one or moreexchangeable optics (e.g., optic 140-A, 140-B) can include fiducials toaid in radial alignment, such as seen in FIGS. 9A and 9B. Alignment canalso involve depth alignment with respect to either the intraocularbase, the eye, or some structure within the eye.

In some cases, there are more or fewer “corresponding couplers” 180 thanthere are couplers 110 of the intraocular base 100. For example, thecouplers of the base may be point couplers while the couplers of theoptic may be a single ring shape. In the illustrated scenario, oneexchangeable optic 140-A is shown with a single corresponding coupler180, which is in the shape of a ring; and the other exchangeable optic140-B is shown with two corresponding couplers 180 that are positionedto both couple to the ring-shaped coupler 110 of the intraocular base100. The coupling between the intraocular base 100 and the exchangeableoptic 140-A, 140-B can be accomplished in a variety of ways, forexample, magnetically, using friction, or chemically. In the illustratedscenario, magnetic coupling is shown.

Of course, while a ring-shape coupler 110 is one example, the one ormore couplers at the intraocular base may be two couplers formed ofmagnetic material such that the coupling is accomplished using atwo-point coupling where a first of the one or more couplers of theintraocular base is disposed at a proximal surface (i.e., the surfacefacing outward from the eye) on one side of the intraocular base and asecond of the one or more couplers is disposed at the proximal surfaceon another side of the intraocular base. The corresponding one or morecouplers would then be disposed at the exchangeable optic in a manner toorient and couple the exchangeable optic to the base. For example, thecorresponding one or more couplers would be disposed in alignment forcoupling to the one or more couplers of the intraocular base.

As mentioned above, the one or more couplers 110 and the correspondingone or more couplers 180 can be formed of magnetic material. Themagnetic material can be any suitable ferromagnetic or ferrimagneticmaterial. The magnetic material is sized and shaped so as to minimize oravoid susceptibility to strong external magnetic fields such as MM(e.g., avoiding/minimizing movement or interference with imaging).

It should be understood that although the examples contained herein makereference to the couplers being magnets or magnetic, other types ofreleasable couplers can be used (e.g., chemical, mechanical, or frictionbased) in certain implementations. The use of magnetic couplers alsoenable certain therapeutics to be applied.

Indeed, referring to FIG. 1B, the same intraocular base 100 can be usedto apply therapeutics 190. In the illustrated scenario, therapeutics 190can be coupled to the intraocular base 100. In some cases, thetherapeutics 190 are applied once the intraocular base 100 is deployedin the eye. In some cases, the therapeutics 190 may be applied beforeoriginal deployment and then optionally reapplied after deployment.

FIGS. 2A-2E illustrate various locations in the eye where anexchangeable optics system can be set. FIGS. 2A-2C show examples of anintraocular base of an exchangeable optics system being positionedwithin a capsular bag of the eye. Referring to FIG. 2A, an intraocularbase 200 of an exchangeable optics system 210 can be positioned withinthe capsular bag 212 of an eye. Through use of magnetic coupling, anexchangeable optic 215 (or therapeutic) can be deployed to (and evenlater removed from) the sulcus space 216 of the eye. Referring to FIG.2B, an intraocular base 220 having extensions 222 can be positionedwithin the capsular bag 212 of an eye. The extensions 222 (or otherprotruding structure) can be extended into the sulcus space 216 throughone or more holes in the capsular bag 212. For example, there may be anopening from cataract surgery through which the extensions 222 canprotrude. In some cases, small openings may be made to allow for theextensions 222 to protrude through. Magnetic, mechanical, or chemicalcouplers may be provided at the end of the extensions 222 for anexchangeable optic 225 that is deployed to (and even later removed from)the sulcus space 216 to couple to. Referring to FIG. 2C, an exchangeableoptics system 230 can be positioned entirely within the capsular bag212.

Referring to FIG. 2D, in some cases, an exchangeable optics system 240can be positioned entirely in the sulcus 216 behind the iris 242, infront of the capsular bag 212. Referring to FIG. 2E, in some cases, anexchangeable optics system 250 can be positioned in the anterior chamberbehind the cornea 252, in front of the iris 242. The examples shown inFIGS. 2D and 2E could work with a patient that is phakic (with nativelens). Advantageously, if the intraocular base is fixed in the anteriorchamber (such as shown in FIG. 2E) or in the sulcus space (such as shownin FIG. 2D), cataract surgery may not be required.

For any of these locations, if weight of the system is ever greater thanzonular strength, an air bladder or portion of the device that floats inaqueous can be incorporated in the intraocular base. This buoyantcomponent of the invention can be permanently incorporated, for examplea compressible foam buoy that has sealed foam used in nauticalequipment, pool toys and body boards. Alternatively, the device can havea reservoir that acts as a bladder that is filled with a gas or anymaterial lighter than water. This would enable adjustable buoyancy basedupon the degree of fill.

As mentioned above, the one or more couplers 110 (and corresponding oneor more couplers 180) can include magnetic material or other releasablefixation material or structures. For example, the releasable couplerscan be in the form of a hook and loop coupler, a memory materialfixation element such as what is utilized for tagging guns for affixingtags to clothing, a button fastener, a screw-type fastener, ahinge-based fastener similar to a cuff link, a suction cup basedmechanism, an adhesive, or any other means of reversible fixation.

FIGS. 3A and 3B illustrate a perspective view and a top view,respectively, of an exchangeable optic with clips for coupling to anintraocular base; FIG. 4 illustrates a perspective view of anexchangeable optic with a screw mount for coupling to an intraocularbase; and FIG. 5 illustrates a side view of part of an exchangeableoptic system with a post and clip coupling.

Referring to FIGS. 3A and 3B, an exchangeable optic 300 can have a clip310 that can attach to a coupler of an intraocular base (not shown). Insome cases, the exchangeable optic 300 can include ribs 320 to assistwith a secure fit, for example, within a main structure of theintraocular base.

Referring to FIG. 4, an exchangeable optic 400 can have a screw mount410 for securing to a corresponding coupler at an intraocular base (notshown). In some cases, the exchangeable optic 400 can include prongs 420to assist with a secure fit, for example, within a coupler and mainstructure of the intraocular base.

Referring to FIG. 5, an exchangeable optic 510 can be coupled to anintraocular base 520 using a post 530 and nitinol clip 540.

For any direct connection between a base and an exchangeable optic (orbetween two exchangeable optics), it is desirable that the couplingmechanism is located within the confines of the anterior rhexis. Thiswill enable direct connection between the exchangeable optic (e.g.,exchangeable optic 225 of FIG. 2B) outside of the capsular bag 212 andthe intraocular base (e.g., intraocular base 220 of FIG. 2B) in thecapsular bag. Alternatively, femtosecond laser or other precisionsurgical platform can not only make the primary rhexis but also make twoor more small secondary opening in the anterior capsule through which acoupling mechanism (e.g., extensions 222) can protrude. The use of thefemtosecond laser or other precision surgical platform to form secondaryopenings through which a coupling mechanism can protrude may serve asecondary function of aligning a lens in a particular axis, which isuseful, for example, with toric IOLs. Indeed, the femtosecond laser orother precision surgical platform can be used to make two additionalholes adjacent to the rhexis at the axis the IOL must be through.

There are numerous coupling mechanisms that may be used instead of or inaddition to magnetic material. In some cases, the exchangeable optic canhave a fixation element that has a shape memory material component thatcan be placed through a hole at the intraocular base through the holesmade in the anterior capsule. Similar to a tagging gun used to attachprice tags to clothing, the T arms can flex when being pushed throughthe hole in the optic haptic junction and return to an open positiononce through the hole.

As is clear to one skilled in the art, this arrangement can be modifiedin numerous ways. For example, in some cases, the T arm fixation elementcan be incorporated into the intraocular base and project through thecapsular bag into the sulcus space. The exchangeable optic can have ahole in it through which the T fixation element projects. This may be apreferable option if capsular bag phimosis causes the capsular bag toshift in position in relation to the hole in the primary optic. Byhaving the T fixation element project beyond the capsular bag, thishelps ensure maintained access to the coupling mechanism, even ifcapsular phimosis occurs. In addition, the T-shape fixation element canbe made of a variety of memory materials including shape memory polymersand shape memory metals. Suitable memory polymers for the describedfixation elements include, but are not limited to, polynorbomene,polycaprolactone, polyenes, nylons, polycyclooctene (PCO), blends of PCOand styrene-butadiene rubber, polyvinyl acetate/polyvinylidinefluoride(PVAc/PVDF), blends of PVAc/PVDF/polymethylmethacrylate (PMMA),polyurethanes, styrene-butadiene copolymers, polyethylene,trans-isoprene, blends of polycaprolactone and n-butylacrylate, andcombinations thereof. Suitable memory metals for the described fixationelements include, but are not limited to, stainless steel, cobalt,nickel, chromium, molybdenum titanium, nitinol, tantalum,platinum-iridium alloy, gold, magnesium, or combinations thereof.Further, it should be understood that other end shapes may be used forthe T shape fixation element. For example, the end shape may be acircle, triangle or any shape that is larger than the hole it is to befixated through.

In some cases, the intraocular base or the exchangeable optic can haveposts that project either through the anterior capsulotomy or throughthe secondary holes created in the anterior capsule. In one suchimplementation with a post projection, an exchangeable optic could thenfit through the posts and an elastic band can be placed over theexchangeable optic onto the post thereby holding the exchangeable opticin place. The elastic band that retains the exchangeable optic canoperate similar to how rubber bands hold a wire in place to the bracketon dental braces. In another implementation of a post projection, thepost could have a thread on it in which a screw can mount. In anotherimplementation, the post can include a hole through which a cotter pinor memory material can be placed through. In another implementation, thepost can include a lever arm. Similar to a cuff link, the post caneither be straight up and down or when turned at the hinge will form aT. This arrangement does not involve shape memory but instead just amechanical hinge. An exchangeable optic with a feature similar to ashirt cuff can be threaded over the fixation element when it is in astraight position and then once in place the hinge can be turned soinstead of straight the post forms a T thereby holding the exchangeableoptic and the intraocular base together.

In some cases, the intraocular base and the exchangeable optic can use asnap-button arrangement, for example, if designed with low enoughfriction.

In some cases, the intraocular base and the exchangeable optic can use atwist on mechanism in conjunction with posts, where the posts include aT or L shaped end and once the posts pass through the opening in theother part, the exchangeable optic can be rotated so that the end ofeach post catches on a surface to hold the two in place. For example, ifone post element is in the shape of a L but the slot it passes throughonly is slightly larger than the horizontal component of the L, then ifthe intraocular base and the exchangeable optic are rotated in relationto each other, the leading edge of the L moves beyond the edge of theslot it passes through thereby holding the intraocular based and theexchangeable optic together. In some cases, a shape memory material canbe incorporated. For example, the L shape can have a projection at thevery end (such as in the form of a very pronounced serif L). Theprojection at the end of the L can fit into a hole that is adjacent tothe notch (e.g., similar to that employed in some ballpoint pens). Thus,as the L shape is threaded through the notch, the projection portion atthe end of the L abuts the edge of the notch and is bent slightly out ofthe way so rotation can continue. Once rotated far enough that theprojection on the L reaches the hole next to the notch and falls intoplace thereby enabling the L to again be coplanar with the intraocularbase and exchangeable optic. In some cases, both the exchangeable opticand the L shaped post can be formed of materials with memory shapeproperties

FIGS. 6A-6D illustrate an exchangeable optics system with multiplestacked lenses. FIG. 6A illustrates an exploded view of an exchangeableoptics system 600 that includes an intraocular base 610 and a pluralityof optics (including first optic 621 and second optic 622). Theintraocular base 610 can have a supporting structure 630 with a hapticring 640 that can be sutured for fixed connection to an eye. One or morecouplers can be on the supporting structure. For example, the one ormore couplers can be point sources or a ring (such as represented bywhite dotted line 650) that is disposed on or goes around acircumference of the supporting structure (see also e.g., FIGS. 11A and11B). Referring to FIG. 6B, the intraocular base 610 can be disposed inthe eye (e.g., in the sulcus space). As shown in FIG. 6C, the firstoptic 621 can be releasably attached to the intraocular base 610.Alternatively, in some cases, the first optic 621 (or a third optic) isfixedly attached to the intraocular base 610 or is built-in to theintraocular base (see e.g., lens 1060 of FIG. 10). Then, as shown inFIG. 6D, the second optic 622 can be releasably attached to theintraocular base 610 over the first optic 621. In some cases, themagnetic force from the intraocular base 610 is sufficient to coupleboth optics. In some cases, the positioning of the two optics enable atleast a portion of the one or more couplers to be dedicated to arespective one of the two (or more) optics. In some cases, the firstoptic 621 includes one or more couplers for the second optic 622 tocouple to. In some cases, the first optic 621 is fixedly attached to theintraocular base 610 and the couplers on the supporting structure areconfigured for attachment of the second optic 622.

FIGS. 7A and 7B illustrate another exchangeable optics system withmultiple stacked lenses; FIG. 7A shows another example of an intraocularbase; and FIG. 7B shows application of a second optic onto theintraocular base and first optic using a delivery system.

Referring to FIG. 7A, an intraocular base 710 can have a supportingstructure 720 with a haptic 730 that can be sutured for fixed connectionto an eye. One or more couplers can be on the supporting structure 720.For example, the one or more couplers can be point sources or a ring(such as represented by white dotted line 740) that is disposed on orgoes around a circumference of the supporting structure (see also e.g.,FIGS. 11A and 11B).

Turning to FIG. 7B, a lens 750 can be easily applied to the intraocularbase 710 via a tool (optic delivery system 760) through a small incisionin the sclera 770. An optic delivery system 760 can include a hook orother fine instrument that can be drawn coaxially, allowing for aminimal incision that minimizes changes to corneal astigmatism anddamage to the ocular structures after optic introduction or exchange.The optic delivery system can coaxially store a capsular bag containinga new optic containing, for example, the secondary lens 750 and enterthrough a minimal incision. As shown in FIG. 7B, once inside the eyeclose to the location of the intraocular base 710, the optic deliverysystem 760 can release the capsular bag close into the sulcus space. Thehook (see FIG. 8) can be used to maneuver the capsular bag or secondarylens to be oriented properly with respect to the intraocular base 710.At some point, the new optic 750 can couple to the intraocular base, atwhich point the hook can optionally be used to properly orient the newoptic with respect to the intraocular base. Fiducial markers may be usedto facilitate orientation and alignment (see e.g., FIGS. 9A and 9B,which can be used under optical coherence tomography—OCT) In some cases,the exchangeable optics (e.g., lens 750) can include an aperture, whichmay be hooked by the instrument of the optic delivery system.

In this illustrated scenario, the lens 750 is a second optic; however,this method can be carried out for the first optic (e.g., optic 621) andeven a replacement second optic (e.g., to replace the second optic 622after optic 622 is applied as shown in FIG. 6D).

FIG. 8 illustrates operation of an optic delivery system. Referring toFIG. 8, an optic delivery system 810 can include a hook 815, which canbe drawn coaxially into the eye within a delivery sleeve of the opticdelivery system 810. In a first step, the hook 815 can be in theextended position. As illustrated in a second step, the hook 815 canengage a hole 825 within the periphery of the optic 820 to enableextraction. As illustrated in the third step, the hook 815 can then bedrawn coaxially back into the optic delivery system 810, bringing theoptic 820 towards the delivery sleeve. At a certain point, the hook 815can be drawn entirely within the optic delivery system 810, at whichpoint the optic 820 can be forced to fold inwards and be drawn with thehook into the optic delivery system 810, such as shown in step 4.

FIGS. 9A and 9B show fiducial designs that can enable preciseorientation of three-dimensional rotation of an optic or haptic.Fiducials can be placed, etched, or drawn onto a lens or other optic toaid in orientation of the lens or other optic once deployed. Thefiducial markers can be of a material suitable for detection by IR,ultrasound, fluorescent, x-ray, MRI, etc. In one implementation, thefiducials can be detectable by an ocular response analyzer (e.g.,optical coherence tomography—OCT). The fiducial markers can be used todetermine precise effective lens position (ELP). Corresponding markerscan be applied to an intraocular base at haptics, on the optional lens,or on the supporting structure, as some examples. In some cases, acorresponding fiducial design may be disposed at the intraocular base(e.g., on main structure region 160 of FIG. 1A).

Referring to FIG. 9A, the fiducial can be L-shaped. Arms of the L shapecan vary. If the size and shape of the L-shaped fiducial is known,apparent length can be used to inform rotation of the lens or optic inthree dimensions. Referring to FIG. 9B, the fiducial can bebulls-eye-shaped (e.g., a single dot within a circle). In particular,use of a bulls-eye shape can allow part of the fiducial to be printed onan opposite side of the lens or optic. The fiducial being on both sidesof the lens or optic can create greater apparent motion of the dotrelative to the circle, allowing a more accurate understanding of itsorientation in three-dimensional space.

A few L shaped fiducials printed on one side of the lens or hapticreceiving system (e.g., as shown in FIG. 9A) or a circle on one side ofthe lens and a dot on the other placed within the circle when viewedanterior/posterior (e.g., providing a bullseye such as shown in FIG. 9B)will enable a sensitive measurement of any tilt. By visualizing thelength of the L arms or where the dot is in relation to the circle it ispossible to determine where the lens or haptic receiver is located.

In some implementations, fiducials are provided on both the exchangeableoptic and the intraocular base that can be read using OCT. The fiducialscan be read in relation to a stationary feature of the eye (e.g.,conjunctival vessel pattern preregistered with cornealtopography/tomography, biometry data, etc.). The OCT can then guideplacement of the optic on haptic. The fiducials support real timetracking of the intraocular base in case the intraocular base moves whenthe exchangeable optic is removed. When the exchangeable optic isrepositioned or replaced, the OCT device can calculate in real time withthe fiducials what position change is necessary.

As mentioned above, an exchangeable optics system can include a varietyof structures for the intraocular base. In addition, the couplers of theintraocular base can be disposed in various locations and be configuredin various shapes. The following examples are directed to exchangeableoptics systems with intraocular bases having magnetic coupling; however,embodiments are not limited thereto.

FIG. 10 illustrates an example exchangeable optics system with magneticexchangeable intraocular lens. Referring to FIG. 10, an exchangeableoptics system 1000 can include an intraocular base 1010 with haptics1020 and a circular magnet coupler 1030; and an exchangeable optic 1040.The exchangeable optic 1040 can be a magnetic optic with a correspondingcircular magnet 1050 around its periphery.

In the illustrated scenario, the haptics 1020 are in the form of a twoC-loop haptic. In some cases, the intraocular base 1010 can furtherinclude a lens 1060. For example, the intraocular base 1010 can besimilar to a conventional IOL, but further includes the one or morecouplers (e.g., here in the form of a magnet disposed at a periphery). Amagnetic optic 1040 can then be deployed, rotated to any preciseorientation, for example aligned using fiducials such as shown in FIGS.9A and 9B, and coupled to the intraocular base structure 1010. In somecases, the exchangeable optic 1040 may not be deployed for potentiallyyears down the line and/or may be replaced years later to deploy a moreprecise lens. An intraocular base structure 1010 that allows fordeployment, rotation, and coupling of a magnetic optic (e.g.,exchangeable optic 1040) can be advantageous, for example, in precisetoric astigmatism correction. In addition, since it is possible to addadditional lenses and/or replace the exchangeable optic 1040, it ispossible to add a further corrective lens after a more disruptivesurgery, add a corrective lens years after the fact, or deploy a moreprecise lens, for example a specially made or three-dimensional printedlens.

FIGS. 11A-11D illustrate another example of an exchangeable opticssystem with magnetic exchangeable ocular lens. Referring to FIGS. 11Aand 11D, in exchangeable optics system 1100, an intraocular base 1110can include a capsular tension ring 1120 with optional tension ringextensions 1125 and two or more couplers 1130. As mentioned above withrespect to FIG. 2B, through use of one or more protrusions such astensions ring extensions 1125, the capsular tension ring 1120 can bedesigned in such a way that two or more magnetic arms (e.g., tensionring extensions 1125 with couplers 1130) emerge through the anteriorcapsulotomy similar to an Ahmed segment thereby enabling optic placementin the sulcus space. Alternatively, the capsular tension ring can bedesigned such that the capsular tension ring does not rise up out of theanterior capsulotomy but instead remains in bag. In some cases, inaddition to the couplers 1130 or as an alternative to the couplers 1130,a secondary magnet ring 1140 can be included, which can provide a360-degree docking platform for magnetic optics 1150, as shown in FIGS.11C and 11D. That is, as shown in FIG. 11C, an optic with correspondingcouplers can be deployed, and attraction between the couplers 1130 onthe arms of the capsular tension ring 1120 (and/or optionally thesecondary magnet ring 1140) and the corresponding couplers on the optic1150 can releasably maintain the optic 1150 in place.

FIGS. 12A-12D illustrate example haptic designs for exchangeable opticssystems. A supporting structure of an intraocular base can beimplemented with haptics of a variety of different shapes and patterns.In addition to the shapes shown in FIGS. 6A and 7A, the two-looped Cshaped haptic such as shown in FIG. 10 and the capsular tension ringconfiguration shown in FIG. 11A, other haptic shapes may be used. Forexample, FIG. 12A shows an exchangeable optics system 1200 with anintraocular base 1210 design having a cruciate haptic pattern 1215 and amagnetic coupling optic 1220. FIG. 12B shows an exchangeable opticssystem 1230 with an intraocular base 1240 design having a haptic design1245 that can facilitate secondary scleral sutured lens similar to theGore Akreos lens and a magnetic coupling optic 1220. FIG. 12C shows anexchangeable optics system 1250 with an intraocular base 1260 designwith four-pronged haptic arm 1265 and a magnetic coupling optic 1220.FIG. 12D shows an exchangeable optics system 1270 with an intraocularbase 1280 design with looped haptic 1285 and a magnetic coupling optic1220.

With cataract surgery, the shape of the corneal as well as the optics ofthe lens and the effective lens position are altered. Even if preciselypositioned in the appropriate location, postoperative shifting of thelens is not uncommon. An exchangeable optics system such as describedherein can address these obstacles. First, by sandwiching the capsularbag between the magnetic optic and magnetic haptic receiver through thebag, the system is less likely to rotate or shift in relation to thecapsular bag. Second, in certain embodiments, such as 3D printing of awavefront guided custom intraocular lens, it may make more sense toallow an intraocular base with a lens haptic system to scar into thecapsular bag. As the capsule contracts, the final effective lensposition of the intraocular base will then be known. By includingfiducials, a wavefront scan can calculate shape of cornea after cataractsurgery, an effective lens position can be determined from fiducials,and this data can be used to 3D print a custom lens when all variablesare achieved. The custom lens can then be attached afterwards to thedetermined specifications. This would enable the ability to not onlyprint wavefront optimized monofocal IOLs, but also custom wavefrontoptimized multifocal and extended depth of focus intraocular lens. Anintraocular base also provides a forward compatible system for anyfuture iteration of lens since the lens can be replaced/exchanged withthe newest iteration of the lens.

In some of such cases, the lens providing the primary power can bedeployed with the intraocular base (see e.g., lens 1060 described withrespect to FIG. 10) and a wavefront guided optic can be deliveredsecondarily for attachment to the intraocular base that has the lens1060. The wavefront guided optic (“second lens”) can be deployed througha far smaller incision and similar to ICL surgery and LASIK, may beamenable to office-based procedures. That is, the secondary optic can bedeployed through a small enough corneal incision or previous surgicalincisions can be accessed, and the additional variability created byreentering cornea can be minimized. This would enable the primary lensand haptic system to be deployed in the bag similar to current IOLs,just with a magnetic system. At a secondary time period in which thecapsular bag has fully contracted, the fiducials provide effective lensposition. In addition, by using topography/tomography and wavefrontmeasurements of the length of the eye, all the optical variables couldbe controlled for. If necessary, the degree of astigmatism induced bypenetrating the cornea to deliver the secondary optic can be controlledfor with custom optic design adjusted to account for the inducedastigmatism. Thus, it is possible to a priori determine effective lensposition (ELP) and determine what custom or non-custom lens would beideal for an eye.

Specialized optics can be applied to an intraocular base as part of thedescribed exchangeable optics systems. FIGS. 13A and 13B illustrate aside view and top view, respectively, of an exchangeable optic withrotatable lens. A lens housing system is provided for a rotationaldesign that enables rotation of a lens of intraocular base or anexchangeable optic. Referring to FIG. 13A, a design for an exchangeableoptic 1300 can have a coupling frame 1310 to which couplers 1320 of anintraocular base 1330 can be attached; a stationary body 1340 that canfit within an opening of the intraocular base 1330 and a rotating body1350 which can rotate in one or two dimensions, depending on couplingbetween the stationary body 1340 and the rotating body 1350.

As previously mentioned, an intraocular base can be used not just tosupport delivery of exchangeable optics, but also to provide a surfacefor delivery of therapeutics. FIGS. 14A-14C an example of anexchangeable optics system with therapeutic delivery.

Magnetic liposomes or nanoparticles can be used in conjunction withmagnetic components of an exchangeable optics system.

In addition to incorporating drug delivery polymeric implants orreservoirs directly into the haptic or optic system of the device, themagnetic components of the intraocular base provide a means of couplingmagnetic nanoparticles and liposomes to the device. The magneticliposomes or particles may be preloaded onto the device and administeredat the time of surgery or after surgery.

Magnetic liposomes or nanoparticles can be coupled to a magneticintraocular base prior to deployment in the eye. Alternatively, or inaddition, liposomes or nanoparticles can be introduced through anintravitreal, transzonular, intracapsular or intracameral approach afterdeployment of a magnetic intraocular base into the eye and be coupled tothe magnetic intraocular base in the eye. The magnetic particles can beused to deliver therapeutics including, but not limited to antibiotics,steroids, and non-steroidal anti-inflammatory drugs (NSAIDs). Thesetherapeutics can be configured such as illustrated in FIGS. 15A-15C tofacilitate attachment to an intraocular base. Instead of rapidly exitingthe eye through the normal outflow pathways, a magnetic intraocular basewould enable the magnetic particles to dwell on the haptic system untilthey degraded or release ferrofluid to the point that the magneticattraction is no longer sufficient to remain bound.

As mentioned above, the magnetic particles used to deliver thetherapeutics can be applied to various forms of an intraocular base.Referring to FIG. 14A, an intraocular base 1410 in the form of acapsular tension ring can be formed of or coated with magnetic materialthat attracts the magnetic particles. In some cases, different regionscan be applied with different therapeutics, for example, a region forantibiotics 1412, a region for steroid 1414, and a region for NSAID1416. Of course, the therapeutics may be applied in a manner that thevarious therapeutics are disbursed throughout the surface of theintraocular base 1410.

Referring to FIG. 14B, an intraocular base 1420, with or without a lens,can include a magnetic coupler/ring 1422 that is used to attach magneticparticles 1430. The magnetic particles 1430 can thus be deployed andattached around the ring 1422.

Referring to FIG. 14C, an intraocular base 1440 with magnetic haptics1442 can be used to attach magnetic particles 1450.

Referring to FIG. 15A, a magnetic particle can be formed of a magnetitecore with polymer coating and polyethylene glycol shell. The magnetitecores can cause the magnetic particle to be attracted to the magneticintraocular base allowing for relatively fine deployment. If a pluralityof magnetite particles is present, attraction between the magneticparticle and the magnetic intraocular base is reduced. The strength ofthe magnetic on the magnetic intraocular base as well as theconcentration of the magnetite, size of polymer particle, and rate ofdegradation can adjust the dwell time to further finetune localizeddosage. In a particular embodiment, rate of polymer degradation can betuned to drug release rate. This can allow the magnetic particle todisassociate after the majority—or even all of—the drug is delivered dueto a decreased attraction.

Referring to FIG. 15B, a magnetic particle can have a plurality ofmagnetic particles within a single polymer particle instead of a singlemagnetite core as shown in FIG. 15A.

Referring to FIG. 15C, a magnetic particle can be formed as a liposomeparticle with a ferrofluid core. A therapeutic can include a liposomeshell, a magnetic ferrofluid within the liposome shell, and a drug ortherapeutic core within the liposome shell. The magnetic ferrofluid anddrug or therapeutic core can be combined inside the liposome shell.Since the ferrofluid and therapeutics are combined within the liposomeshell, release of the drug or therapeutic can coincide with release ofthe ferrofluid. In certain implementations, rate of ferrofluid releasecan be tuned to drug release rate so when the majority of drug isreleased the degree of attraction between the liposome and intraocularbase is reduced to the point at which the liposome dissociates and thencan freely flow through the trabecular meshwork out of the eye.

Since free iron is known to be toxic to the retina, magneticnanoparticles are contained within a biocompatible shell much likecurrent iron-based MM contrast agents such as Ferridex® from BerlexLaboratories Inc. The nanoparticles are of sufficient size in order forthem to freely egress out of the eye through the trabecular meshworkwhen the extraocular magnet is removed. The nanoparticles are thencleared by the liver like other iron-based nanoparticles currently usedclinically.

The biocompatible material for the biocompatible shell of the magneticnanoparticles can be selected from the group consisting of polyvinylalcohol, sodium polyacrylate, acrylate polymers, hyaluronase polymers,collagen membrane, Porous HA/TCP ceramic composite, hydroxyapatite bonecement, PVP/PMMA, tricalcium phosphate, hydroxyapatite coated collagenfibers, calcium sulphate, hydroxyapatite (HAp), phosphorylcholine (PC),silicone, ultrahigh molecular weight polyethylene, polyethylene,acrylic, nylon, Polyurethane, Polypropylene, poly(methyl methacrylate),Teflon, Dacron, acetal, polyester, silicone-collagen composite,polyaldehyde, polyvinyl chloride), silicone-acrylate,poly(tetrafluoroethylene), hydroxyethyl methacrylate (HEMA), poly(methylmethacrylate) (PMMA), poly(glycolide lactide), poly(glycolic acid),tetrafluoroethylene, hexafluoropropylene, poly(glycolic acid),poly(lactic acid), desaminotyrosyltyrosine ethyl ester, polydioxanone,fibrin, gelatin, hyaluronan, tricalcium phosphate, polyglycolide (PGA),polycaprolactone, poly (lactide-co-glycolide), polyhydroxybutyrate,polyhydroxyvalerate, trimethylene carbonate, polyanhydrides,polyorthoesters, poly(vinyl alcohol), poly(N-vinyl 2-pyrrolidone),poly(ethylene glycol), poly(hydroxyethylmethacrylate),n-vinyl-2-pyrrolidone, methacrylic acid, methyl methacrylate, and maleicanhydride, polycaprolactone, poly(amino acids), poly(L-lysine),poly(l-ornithine), poly(glutamic acid), polycyanoacrylates,polyphosphazenes, poly(lactic acid), poly(glycolic acid), crown ethers,cyclodextrins, cyclophanes, ethylene glycol, Methylacrylate,Para-xylylene, Biodegradable Copolymers, Copolymer Surface Coatings,Starch Polymers, Polylactic Acid, Cellophane, Tyrosine PolycarbonatesLactide and Glycolide Polymers, Collagen, PTFE, silicone, Keratin-BasedMaterials, Fibrous Composites—Carbon Fiber and Particles, PolymerComposites, Artificial/Natural Material Composites, Glass-Ceramic/MetalComposites, Glass-Ceramic/Nonmetal Composites, Dental Composites,hydrogels, timed-release foams, and polymeric carriers.

According to certain implementations, the magnetic nanoparticles caninclude metal oxide and polymeric or liposomal formulations. Exampleliposomes include elements from the group consisting of fatty acids,fatty acids derivatives, mono-, di and triglycerides, phospholipids,sphingolipids, cholesterol and steroid derivatives, oils, vitamins andterpenes including but not limited to egg yolk L-phosphatidylcholine(EPC), 1,2-dimyristoyl-sn-glycero-3-phosphatidylcholine (DMPC),1,2-dipalmitoyl-sn-glycero-3-phosphatidylcholine (DPPC),1,2-dioleoyl-sn-glycero-3-phosphatidylcholine (DOPC),1,2-distearoyl-sn-glycero-3-phosphatidylcholine (DSPC),1,2-dilauroyl-sn-glycero-3-phosphatidylcholine (DLPC),1,2-dioleoyl-sn-glycero-3-phosphaethanolamine (DOPE),1-palmitoyl-oleoyl-sn-glycero-3-phosphoethanolamine (POPE),1,2-dimyristoyl-sn-glycero-3-phosphoethanolamine (DMPE),1,2-dipalmitoyl-sn-glycero-3-phosphoethanolamine (DPPE), and1,2-distearoyl-sn-glycero-3-phospharthanolamine (DSPE), phosphatidicacids, phosphatidyl cholines with both saturated and unsaturated lipids,phosphatidyl ethanolamines, phosphatidylglycerols, phosphatidylserines,phosphatidylinositols, lysophosphatidyl derivatives, cardiolipin,13-acyl-y-alkyl phospholipids, di-oleoyl phosphatidylcholine,di-myristoyl phosphatidylcholine, di-pentadecanoyl phosphatidylcholine,di-lauroyl phosphatidylcholine, dipalmitoylphosphatidylcholine,distearoylphosphatidylcholine, diarachidoylphosphatidylcholine,dibehenoylphosphatidylcholine, ditricosanoylphosphatidylcholine,dilignoceroylphatidylcholine; and phosphatidylethanolamines.

The polymer formulations (e.g., forming a matrix for the nanoparticles)can be selected from the group consisting of poly(acrylamide),poly(N-isopropylacrylamide),polyisopropylacrylamide-co-1-vinylimidazole),poly(N,N-dimethylacrylamide), poly(N,N-dimethylacrylamide),poly(1-vinylimidazole), poly(sodium acrylate), poly(sodiummethacrylate), poly(2-hydroxyethylmethacrylate) (HEMA), polyN-dimethylaminoethyl methacrylate) (DMAEMA), poly(Ntris(hydroxymethyl)methylacrylamide),poly(1-(3-methacryloxy)propylsulfonic acid) (sodium salt),poly(allylamine), poly(N-acryloxysuccinimide), poly(N-vinylcaprolactam),poly(1-vinyl-2-pyrrolidone),poly(2-acrylamido-2-methyl-1-propanesulfonic acid) (sodium salt),poly((3-acrylamidopropyl) trimethylammonium chloride), andpoly(diallyldimethylammonium chloride), poly(hydroxy acids),polyanhydrides, polyorthoesters, polyamides, polycarbonates,polyalkylenes, polyalkylene glycols, polyalkylene oxides, polyalkyleneterepthalates, polyvinyl alcohols, polyvinyl ethers, polyvinyl esters,polyvinyl halides, polyvinylpyrrolidone, polysiloxanes, poly(vinylalcohols), poly(vinyl acetate), polystyrene, polyurethanes andco-polymers thereof, synthetic celluloses, polyacrylic acids,poly(butyric acid), poly(valeric acid), andpoly(lactide-co-caprolactone), ethylene vinyl acetate, copolymers andblends thereof.

Advantageously, the described intraocular base enables customization andexchange of optics as well as delivery of therapeutics.

Although the subject matter has been described in language specific tostructural features and/or acts, it is to be understood that the subjectmatter defined in the appended claims is not necessarily limited to thespecific features or acts described above. Rather, the specific featuresand acts described above are disclosed as examples of implementing theclaims and other equivalent features and acts are intended to be withinthe scope of the claims.

What is claimed is:
 1. An exchangeable optics system comprising: anintraocular base comprising: one or more couplers for releasablycoupling to an exchangeable optic or therapeutic; and a supportingstructure for physically supporting the exchangeable optic ortherapeutic when coupled to the intraocular base via the one or morecouplers, the supporting structure comprising haptics for fixedlycoupling the intraocular base within an eye, a main structure, and afirst set of fiducials; and a therapeutic releasably coupled to theintraocular base, wherein the supporting structure comprises anintraocular lens (IOL), and wherein the main structure comprises aprimary optic of the intraocular lens, wherein the one or more couplersare magnetic couplers located on a periphery of the main structure or onthe haptics, wherein the therapeutic comprises a magnetic particle, andwherein the magnetic particle comprises: a liposome shell; a magneticferrofluid within the liposome shell; and a drug or therapeutic corewithin the liposome shell.
 2. The exchangeable optics system of claim 1,further comprising: the exchangeable optic, wherein the exchangeableoptic comprises one or more corresponding couplers for coupling with oneor more magnetic couplers located on a periphery of the main structure.3. The exchangeable optics system of claim 2, wherein the exchangeableoptic comprises a wavefront guided optic and the primary optic providesbase optical power.
 4. The exchangeable optics system of claim 2,further comprising: a second set of fiducials on the exchangeable optic.5. The exchangeable optics system of claim 1, wherein the one or morecouplers comprises a magnetic ring on the main structure.
 6. Theexchangeable optics system of claim 1, wherein the one or more couplersreleasably coupling the therapeutic to the intraocular base comprisesmagnetic material on a haptic of the supporting structure or a magneticring on the supporting structure.